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New long-term data show Shingrix continues to provide high protection against shingles in adults aged 50 and over for more than a decade – GSK

Written by | 26 Apr 2024 | Immunology

GSK plc announced positive data from the ZOSTER-049 long-term follow-up phase III trial which followed participants for up to approximately 11 years following initial vaccination with Shingrix (Recombinant Zoster Vaccine or RZV) . The final trial data demonstrate that RZV maintains efficacy against shingles for more than a decade in adults over 50. The data will be presented at ESCMID Global (European Society of Clinical Microbiology and Infectious Diseases) 2024, formerly known as ECCMID in Barcelona, Spain (27–30 April 2024).

The results from ZOSTER-049, an extension from two phase III clinical trials in adults aged 50 and over (ZOE-50 and ZOE-70), include : i. 79.7% vaccine efficacy (VE) in adults aged greater than 50 cumulatively within the period from year six to year 11 after vaccination (95% CI 73.7–84.6). ii. 82.0% VE in adults greater than 50 at year 11 (95% CI 63.0–92.2), showing VE remains high in each year after vaccination iii. 73.1% VE in adults aged greater than 70 cumulatively from six to 11 years after vaccination (95% CI 62.9–80.9) showing high VE rates across all age groups.

Dr Javier Díez-Domingo, Principal Investigator, FISABIO (Foundation for the Promotion of Health and Biomedical Research of the Valencian Community, Spain) said: “These final data demonstrate continued protection over more than a decade with high efficacy maintained in both the 50+ and 70+ age groups. Infectious diseases like shingles pose a significant risk to adults due to the natural decline in our immune system, and these data represent a remarkable advancement in our understanding of what can be achieved long-term for effective protection against shingles.”

Phil Dormitzer, Senior Vice President, Head of Vaccines R&D, said: “These data go far beyond the typical long-term follow-up period for a trial, tracking the efficacy of vaccination for some participants as they aged into their 70s, 80s and 90s. With the vaccine now included in many national immunisation programmes around the world, these data add to the body of evidence on the extended long-term protection against shingles and provide further confidence to inform public immunisation strategies.”

Globally, shingles will affect up to 1 in 3 people in their lifetimes. A variety of factors can increase the risk of developing shingles, including advancing age and immunodeficiency or immunosuppression, as well as other chronic conditions such as COPD, diabetes mellitus, and asthma. Shingles typically presents as a rash, with painful blisters across the chest, abdomen or face, with the pain often described as aching, burning, stabbing or shock-like. Following the rash, up to 30% of people experience post-herpetic neuralgia (PHN) a long-lasting nerve pain that can last weeks or months and can occasionally persist for several years. Shingles is also associated with significant healthcare and human cost, with 57% of people with shingles reported missing work for an average of 9.1 days.

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